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Safety and Efficacy Study of Nab®-Paclitaxel With CC-486 or Nab®-Paclitaxel With Durvalumab, and Nab®-Paclitaxel Monotherapy as Second/Third-line Treatment for Advanced Non-small Cell Lung Cancer (abound2L+)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02250326
Recruitment Status : Active, not recruiting
First Posted : September 26, 2014
Results First Posted : August 10, 2018
Last Update Posted : December 30, 2019
Sponsor:
Information provided by (Responsible Party):
Celgene

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Carcinoma, Non-Small-Cell Lung
Interventions Drug: nab-paclitaxel IV
Drug: CC-486
Drug: Duravalumab
Enrollment 240
Recruitment Details This was a multicenter study with 34 sites from the United States, Canada, France, Germany, Italy, Spain and the United Kingdom.
Pre-assignment Details Eligible participants included those with advanced non-small cell lung cancer who had received no more than one prior containing chemotherapy regimen. Immunotherapy as a prior line of treatment was allowed. Randomization was stratified by eastern cooperative oncology group performance status, gender and the smoking status of the participant.
Arm/Group Title Nab-Paclitaxel + CC-486 Combination Arm Nab-Paclitaxel + Durvalumab Combination Arm Nab-Paclitaxel Monotherapy Arm
Hide Arm/Group Description Participants received nab-paclitaxel 100 mg/m^2 by intravenous (IV) infusion over 30 minutes on Days 8 and 15 and CC-486 200 mg tablets on Days 1 to 14 of each 21-day treatment cycle until disease progression (DP), development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care. Participants received nab-paclitaxel 100 mg/m^2 by IV infusion over 30 minutes on Days 1and 8 and durvalumab (durva) 1125 mg/m^2 by IV infusion over 1 hour on Day 15 of each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care. Participants received nab-paclitaxel 100 mg/m^2 by intravenous infusion over 30 minutes on Days 1 and 8 each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
Period Title: Treatment Period
Started 81 79 80
Treated Population 79 78 79
Completed [1] 0 [2] 15 [3] 3 [2]
Not Completed 81 64 77
Reason Not Completed
Death             1             12             2
Adverse Event             8             4             8
Progressive Disease             42             36             45
Symptomatic Deterioration             9             4             10
Withdrawal by Subject             11             5             4
Miscellaneous             8             2             7
Randomized or assigned; not treated             2             1             1
[1]
Completed = Participants still on treatment at the end of the time of the data cut-off date.
[2]
Data Cut-off Date = 30 August 2017
[3]
Data Cut-off Date = 23 December 2017
Period Title: Follow-Up Period
Started 67 43 64
Completed [1] 18 13 26
Not Completed 49 30 38
Reason Not Completed
Death             46             26             32
Unknown or Missing             2             3             3
Lost to Follow-up             1             1             3
[1]
Completed = Participants in follow-up at the time of data cut-off date
Arm/Group Title Nab-Paclitaxel + CC-486 Combination Arm Nab-Paclitaxel + Durvalumab Combination Arm Nab-Paclitaxel Monotherapy Arm Total
Hide Arm/Group Description Participants received nab-paclitaxel 100 mg/m^2 by intravenous (IV) infusion over 30 minutes on Days 8 and 15 and CC-486 200 mg tablets on Days 1 to 14 of each 21-day treatment cycle until disease progression (DP), development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care. Participants received nab-paclitaxel 100 mg/m^2 by IV infusion over 30 minutes on Days 1and 8 and durvalumab (durva) 1125 mg/m^2 by IV infusion over 1 hour on Day 15 of each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care. Participants received nab-paclitaxel 100 mg/m^2 by intravenous infusion over 30 minutes on Days 1 and 8 each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care. Total of all reporting groups
Overall Number of Baseline Participants 81 79 80 240
Hide Baseline Analysis Population Description
Intent to Treat (ITT) Population included all assigned participants regardless of whether the participant received any investigational product (IP) or had any efficacy assessments performed.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 81 participants 79 participants 80 participants 240 participants
64.0  (9.00) 62.7  (10.74) 62.6  (9.58) 63.1  (9.77)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 81 participants 79 participants 80 participants 240 participants
Female
31
  38.3%
25
  31.6%
30
  37.5%
86
  35.8%
Male
50
  61.7%
54
  68.4%
50
  62.5%
154
  64.2%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 81 participants 79 participants 80 participants 240 participants
Asian
0
   0.0%
0
   0.0%
2
   2.5%
2
   0.8%
Black or African American
0
   0.0%
1
   1.3%
2
   2.5%
3
   1.3%
White
67
  82.7%
77
  97.5%
63
  78.8%
207
  86.3%
Other
2
   2.5%
0
   0.0%
1
   1.3%
3
   1.3%
Not Reported
12
  14.8%
1
   1.3%
12
  15.0%
25
  10.4%
Eastern Cooperative Oncology Group (ECOG) Performance Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 81 participants 79 participants 80 participants 240 participants
0 = Fully Active
25
  30.9%
18
  22.8%
26
  32.5%
69
  28.7%
1 = Restrictive but ambulatory
56
  69.1%
61
  77.2%
54
  67.5%
171
  71.3%
2 = Ambulatory but unable to work
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Missing
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Description: ECOG performance status is used by doctors and researchers to assess how a subject's disease is progressing, assess how the disease affects the daily living activities of the subject and determine appropriate treatment and prognosis. 0 = Fully Active (Most Favorable Activity); 1 = Restricted activity but ambulatory; 2 = Ambulatory but unable to carry out work activities; 3 = Limited Self-Care; 4 = Completely Disabled, No self-care (Least Favorable Activity)
Smoking History  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 81 participants 79 participants 80 participants 240 participants
Current Smoker
18
  22.2%
13
  16.5%
13
  16.3%
44
  18.3%
Past Smoker
54
  66.7%
57
  72.2%
63
  78.8%
174
  72.5%
Never Smoked
9
  11.1%
9
  11.4%
4
   5.0%
22
   9.2%
Confirmed Histology  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 81 participants 79 participants 80 participants 240 participants
Adenocarcinoma
78
  96.3%
48
  60.8%
75
  93.8%
201
  83.8%
Large Cell Carcinoma
1
   1.2%
3
   3.8%
4
   5.0%
8
   3.3%
Adenosquamous Carcinoma
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Carcinoid Tumor
0
   0.0%
1
   1.3%
0
   0.0%
1
   0.4%
Other
2
   2.5%
3
   3.8%
1
   1.3%
6
   2.5%
Squamous Cell
0
   0.0%
23
  29.1%
0
   0.0%
23
   9.6%
Missing
0
   0.0%
1
   1.3%
0
   0.0%
1
   0.4%
Disease Stage at Enrollment   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 81 participants 79 participants 80 participants 240 participants
Stage IIIa
1
   1.2%
0
   0.0%
1
   1.3%
2
   0.8%
Stage IIIb
0
   0.0%
3
   3.8%
3
   3.8%
6
   2.5%
Stage IV
80
  98.8%
75
  94.9%
76
  95.0%
231
  96.3%
Not Reported
0
   0.0%
1
   1.3%
0
   0.0%
1
   0.4%
[1]
Measure Description: Disease stage means how big the tumor is and how far it has spread. Disease stages range from 0 (no spread) to IV (spread throughout the body). Stage 1 - the cancer is small and hasn't spread to the lymph nodes; Stage II - the cancer has spread to some lymph nodes near the tumor; Stage IIIA the cancer has spread to lymph nodes on the same side of the tumor; Stage IIIB - the the cancer has spread to the lymph nodes above the collarbone or in the opposite side of the chest tumor; Stage IV - the cancer has spread to other organs such as the other lung, brain or liver.
1.Primary Outcome
Title Kaplan Meier Estimate of Progression-Free Survival (PFS) as Assessed by the Investigator
Hide Description Progression-free survival was defined as the time in months from the date of randomization/assignment to the date of disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria documented by computed tomography (CT) scan, not including symptomatic deterioration, or death (any cause) on or prior to the clinical cut-off date, which ever occurred earlier. Participants who did not have disease progression and had not died, regardless of whether they were discontinued from treatment, were censored at the date of last tumor assessment, on or prior to the clinical cut-off date that the participant was progression free. Progressive Disease was defined as at least a 20% increase in the sum of diameters of target lesions from nadir.
Time Frame From date of first dose of IP to DP; up to data cut-off date of 30 August (Aug) 2017 for nab-paclitaxel and CC-486 + nab-paclitaxel and 23 December (Dec) 2017 for Durva + nab-paclitaxel; participants were followed for PFS for up to 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population included all randomized or assigned participants regardless of whether the participant received any study drug or had any efficacy assessments performed.
Arm/Group Title Nab-Paclitaxel + CC-486 Combination Arm Nab-Paclitaxel + Durvalumab Combination Arm Nab-Paclitaxel Alone
Hide Arm/Group Description:
Participants received nab-paclitaxel 100 mg/m^2 by intravenous (IV) infusion over 30 minutes on Days 8 and 15 and CC-486 200 mg tablets on Days 1 to 14 of each 21-day treatment cycle until disease progression (DP), development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
Participants received nab-paclitaxel 100 mg/m^2 by IV infusion over 30 minutes on Days 1and 8 and durvalumab (durva) 1125 mg/m^2 by IV infusion over 1 hour on Day 15 of each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
Participants received nab-paclitaxel 100 mg/m^2 by intravenous infusion over 30 minutes on Days 1 and 8 each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
Overall Number of Participants Analyzed 81 79 80
Median (95% Confidence Interval)
Unit of Measure: months
3.2
(2.30 to 4.30)
4.5
(3.45 to 5.88)
4.2
(2.79 to 5.06)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nab-Paclitaxel + CC-486 Combination Arm, Nab-Paclitaxel Alone
Comments Based on stratified Cox proportional hazards regression model.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.3
Confidence Interval (2-Sided) 95%
0.90 to 1.94
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants Who Achieved a Complete Response (CR), Partial Response (PR) or Stable Disease (SD) According to RECIST V 1.1 Criteria
Hide Description

Disease control rate was defined as the percentage of participants who had a CR, PR or SD during the course of the study, according to RECIST version 1.1 criteria, as evaluated by the investigator. RECIST Version 1.1 criteria is defined as follows:

  • Complete Response is the disappearance of all target lesions;
  • Partial Response is at least a 30% decrease in the sum of diameters of target lesions from baseline;
  • Stable Disease is neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for progressive disease. Responses were evaluated every 6 weeks.
Time Frame Up to 30 Aug 2017 for nab-paclitaxel and CC-486 + nab-paclitaxel and 23 Dec 2017 for Durva + nab-paclitaxel; maximum treatment duration = 82.1 weeks, 52.6 weeks and 66.1 weeks for nab-paclitaxel, CC-486 + nab-paclitaxel and Durva + nab-paclitaxel
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population included all randomized or assigned participants regardless of whether the participant received any study drug or had any efficacy assessments performed.
Arm/Group Title Nab-Paclitaxel + CC-486 Combination Arm Nab-Paclitaxel + Durvalumab Combination Arm Nab-Paclitaxel Alone
Hide Arm/Group Description:
Participants received nab-paclitaxel 100 mg/m^2 by intravenous (IV) infusion over 30 minutes on Days 8 and 15 and CC-486 200 mg tablets on Days 1 to 14 of each 21-day treatment cycle until disease progression (DP), development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
Participants received nab-paclitaxel 100 mg/m^2 by IV infusion over 30 minutes on Days 1and 8 and durvalumab (durva) 1125 mg/m^2 by IV infusion over 1 hour on Day 15 of each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
Participants received nab-paclitaxel 100 mg/m^2 by intravenous infusion over 30 minutes on Days 1 and 8 each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
Overall Number of Participants Analyzed 81 79 80
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
65.4
(54.0 to 75.7)
70.9
(59.6 to 80.6)
67.5
(56.1 to 77.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nab-Paclitaxel + CC-486 Combination Arm, Nab-Paclitaxel Alone
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Disease Control Rate Ratio
Estimated Value 0.97
Confidence Interval (2-Sided) 95%
0.778 to 1.207
Estimation Comments 95% CI was calculated using Clopper-Pearson method.
Other Statistical Analysis Direction of Disease Control Rate Ratio is DCR of Nab-Paclitaxel + CC-486 Combination Arm over DCR of Nab-Paclitaxel Alone
3.Secondary Outcome
Title Percentage of Participants Who Achieved a Best Overall Response of Complete Response or Partial Response According to RECIST V 1.1 Criteria
Hide Description Overall Response was defined as percentage of participants who achieved a radiologic confirmed complete response or partial response according to RECIST V 1.1 criteria and compared with baseline among all tumor assessments, where baseline was the last CT obtained prior to or on Day 1 of treatment. Per RECIST V 1.1 criteria, a CR is defined as a disappearance of all target lesions; a PR is defined as having at least a 30% decrease in the sum of diameters of target lesions from baseline. Responses were evaluated every 6 weeks.
Time Frame Up to 30 Aug 2017 for nab-paclitaxel and CC-486 + nab-paclitaxel and 23 Dec 2017 for Durva + nab-paclitaxel; maximum treatment duration = 82.1 weeks, 52.6 weeks and 66.1 weeks for nab-paclitaxel, CC-486 + nab-paclitaxel and Durva + nab-paclitaxel
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population included all randomized or assigned participants regardless of whether the participant received any study drug or had any efficacy assessments performed.
Arm/Group Title Nab-Paclitaxel + CC-486 Combination Arm Nab-Paclitaxel + Durvalumab Combination Arm Nab-Paclitaxel Alone
Hide Arm/Group Description:
Participants received nab-paclitaxel 100 mg/m^2 by intravenous (IV) infusion over 30 minutes on Days 8 and 15 and CC-486 200 mg tablets on Days 1 to 14 of each 21-day treatment cycle until disease progression (DP), development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
Participants received nab-paclitaxel 100 mg/m^2 by IV infusion over 30 minutes on Days 1and 8 and durvalumab (durva) 1125 mg/m^2 by IV infusion over 1 hour on Day 15 of each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
Participants received nab-paclitaxel 100 mg/m^2 by intravenous infusion over 30 minutes on Days 1 and 8 each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
Overall Number of Participants Analyzed 81 79 80
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
13.6
(7.0 to 23.0)
27.8
(18.3 to 39.1)
16.3
(8.9 to 26.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nab-Paclitaxel + CC-486 Combination Arm, Nab-Paclitaxel Alone
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Overall Response Rate Ratio
Estimated Value 0.84
Confidence Interval (2-Sided) 95%
0.398 to 1.754
Estimation Comments 95% CI was calculated using Clopper-Pearson method.
Other Statistical Analysis Direction of Overall Response Rate Ratio is ORR of Nab-Paclitaxel + CC-486 Combination Arm over ORR of nab-Paclitaxel Alone.
4.Secondary Outcome
Title Kaplan Meier Estimate of Overall Survival (OS)
Hide Description Overall survival was defined as the time in months between randomization/treatment assignment and death from any cause. Participants who were still alive as of the clinical cut-off date had their OS censored at the date of last contact or clinical cut-off, whichever was earlier. Participants who were lost to follow-up prior to the end of the study or who were withdrawn from the study were censored at the time of last contact.
Time Frame Up to 30 Aug 2017 for nab-paclitaxel and CC-486 + nab-paclitaxel and 23 Dec 2017 for Durva + nab-paclitaxel; participants were followed for overall survival up to 30 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population included all randomized or assigned participants regardless of whether the participant received any study drug or had any efficacy assessments performed.
Arm/Group Title Nab-Paclitaxel + CC-486 Combination Arm Nab-Paclitaxel + Durvalumab Combination Arm Nab-Paclitaxel Alone
Hide Arm/Group Description:
Participants received nab-paclitaxel 100 mg/m^2 by intravenous (IV) infusion over 30 minutes on Days 8 and 15 and CC-486 200 mg tablets on Days 1 to 14 of each 21-day treatment cycle until disease progression (DP), development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
Participants received nab-paclitaxel 100 mg/m^2 by IV infusion over 30 minutes on Days 1and 8 and durvalumab (durva) 1125 mg/m^2 by IV infusion over 1 hour on Day 15 of each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
Participants received nab-paclitaxel 100 mg/m^2 by intravenous infusion over 30 minutes on Days 1 and 8 each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
Overall Number of Participants Analyzed 81 79 80
Median (95% Confidence Interval)
Unit of Measure: Months
8.1
(6.64 to 11.86)
10.1 [1] 
(7.75 to NA)
17.0 [1] 
(8.21 to NA)
[1]
The 95% CI upper bound of the median OS time is not estimable, because the survival rate is greater than 40% for all values of time, therefore, no time that corresponding to the 40% survival rate and below.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nab-Paclitaxel + CC-486 Combination Arm, Nab-Paclitaxel Alone
Comments Based on stratified Cox proportional hazards regression model.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.7
Confidence Interval (2-Sided) 95%
1.08 to 2.57
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Entire Treatment Period
Hide Description TEAEs were defined as any adverse event or serious adverse event that occurred or worsened on or after the day of the first dose of the IP through 28 days after the last dose of IP for Arms A and C or up to 90 days after the last dose for Arm B, and those SAEs made known to the investigator at any time thereafter that are suspected of being related to IP. A serious AE (SAE) = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs were graded based on National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 and the scale: Grade 1 = Mild l intervention/therapy required Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Death.
Time Frame TEAEs were collected up to 4 weeks after receiving last dose of IP for nab-paclitaxel and CC-486 + nab-paclitaxel, and up to 90 days after the last IP dose for Durva + nab-paclitaxel; TEAEs were collected up to 86.1 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population included all participants who were randomized or assigned and received at least 1 dose of study drug.
Arm/Group Title Nab-Paclitaxel + CC-486 Combination Arm Nab-Paclitaxel + Durvalumab Combination Arm Nab-Paclitaxel Alone
Hide Arm/Group Description:
Participants received nab-paclitaxel 100 mg/m^2 by intravenous (IV) infusion over 30 minutes on Days 8 and 15 and CC-486 200 mg tablets on Days 1 to 14 of each 21-day treatment cycle until disease progression (DP), development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
Participants received nab-paclitaxel 100 mg/m^2 by IV infusion over 30 minutes on Days 1and 8 and durvalumab (durva) 1125 mg/m^2 by IV infusion over 1 hour on Day 15 of each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
Participants received nab-paclitaxel 100 mg/m^2 by intravenous infusion over 30 minutes on Days 1 and 8 each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
Overall Number of Participants Analyzed 79 78 79
Measure Type: Count of Participants
Unit of Measure: Participants
TEAE
79
 100.0%
78
 100.0%
78
  98.7%
Serious TEAE
30
  38.0%
37
  47.4%
29
  36.7%
Grade (GR) 3/4 TEAE
48
  60.8%
53
  67.9%
47
  59.5%
Grade 3 or Higher
49
  62.0%
55
  70.5%
47
  59.5%
Treatment Related TEAE
74
  93.7%
71
  91.0%
68
  86.1%
Treatment Related Serious TEAE
11
  13.9%
17
  21.8%
5
   6.3%
Treatment Related GR 3 or Higher TEAE
32
  40.5%
32
  41.0%
25
  31.6%
TEAE With Action to Reduce/Interrupt IP
49
  62.0%
57
  73.1%
38
  48.1%
Treatment-Related to Reduce or Interrupt IP
36
  45.6%
32
  41.0%
27
  34.2%
TEAE with Action Taken to Withdraw IP
8
  10.1%
9
  11.5%
8
  10.1%
TEAE with Fatal Outcome
4
   5.1%
12
  15.4%
3
   3.8%
Treatment Related TEAE with Fatal Outcome
0
   0.0%
4
   5.1%
1
   1.3%
6.Secondary Outcome
Title Percentage of Participants Who Discontinued Study Treatment
Hide Description The discontinuation rate was defined as the percentage of participants who had study drug discontinued and was assessed throughout the conduct of the study.
Time Frame Up to 30 Aug 2017 for nab-paclitaxel and CC-486 + nab-paclitaxel and 23 Dec 2017 for Durva + nab-paclitaxel; maximum treatment duration = 82.1 weeks, 52.6 weeks and 66.1 weeks for nab-paclitaxel, CC-486 + nab-paclitaxel and Durva + nab-paclitaxel
Hide Outcome Measure Data
Hide Analysis Population Description
Treated population included all participants who were randomized or assigned and received at least 1 dose of study drug.
Arm/Group Title Nab-Paclitaxel + CC-486 Combination Arm Nab-Paclitaxel + Durvalumab Combination Arm Nab-Paclitaxel Alone
Hide Arm/Group Description:
Participants received nab-paclitaxel 100 mg/m^2 by intravenous (IV) infusion over 30 minutes on Days 8 and 15 and CC-486 200 mg tablets on Days 1 to 14 of each 21-day treatment cycle until disease progression (DP), development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
Participants received nab-paclitaxel 100 mg/m^2 by IV infusion over 30 minutes on Days 1and 8 and durvalumab (durva) 1125 mg/m^2 by IV infusion over 1 hour on Day 15 of each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
Participants received nab-paclitaxel 100 mg/m^2 by intravenous infusion over 30 minutes on Days 1 and 8 each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
Overall Number of Participants Analyzed 79 79 80
Measure Type: Number
Unit of Measure: percentage of participants
100.0 80.8 96.2
7.Secondary Outcome
Title Dose Intensity Per Week of Nab-Paclitaxel
Hide Description Dose intensity was the cumulative dose divided by the dosing period in weeks.
Time Frame Up to 30 Aug 2017 for nab-paclitaxel and CC-486 + nab-paclitaxel and 23 Dec 2017 for Durva + nab-paclitaxel; maximum treatment duration = 82.1 weeks, 52.6 weeks and 66.1 weeks for nab-paclitaxel, CC-486 + nab-paclitaxel and Durva + nab-paclitaxel
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Hide Analysis Population Description
The treated population consisted of all participants who were randomized or assigned and received at least 1 dose of IP.
Arm/Group Title Nab-Paclitaxel + CC-486 Combination Arm Nab-Paclitaxel + Durvalumab Combination Arm Nab-Paclitaxel Alone
Hide Arm/Group Description:
Participants received nab-paclitaxel 100 mg/m^2 by intravenous (IV) infusion over 30 minutes on Days 8 and 15 and CC-486 200 mg tablets on Days 1 to 14 of each 21-day treatment cycle until disease progression (DP), development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
Participants received nab-paclitaxel 100 mg/m^2 by IV infusion over 30 minutes on Days 1and 8 and durvalumab (durva) 1125 mg/m^2 by IV infusion over 1 hour on Day 15 of each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
Participants received nab-paclitaxel 100 mg/m^2 by intravenous infusion over 30 minutes on Days 1 and 8 each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
Overall Number of Participants Analyzed 79 78 79
Mean (Standard Deviation)
Unit of Measure: mg/m^2/week
54.73  (11.390) 57.18  (13.605) 58.61  (14.893)
8.Secondary Outcome
Title Dose Intensity Per Week of CC-486
Hide Description Dose intensity was the cumulative dose divided by the dosing period in weeks.
Time Frame Up to 30 Aug 2017 for nab-paclitaxel and CC-486 + nab-paclitaxel and 23 Dec 2017 for Durva + nab-paclitaxel; maximum treatment duration = 82.1 weeks, 52.6 weeks and 66.1 weeks for nab-paclitaxel, CC-486 + nab-paclitaxel and Durva + nab-paclitaxel
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Hide Analysis Population Description
The treated population consisted of all participants who randomized or assigned and received at least 1 dose of IP.
Arm/Group Title Nab-Paclitaxel + CC-486 Combination Arm
Hide Arm/Group Description:
Participants received nab-paclitaxel 100 mg/m^2 by intravenous (IV) infusion over 30 minutes on Days 8 and 15 and CC-486 200 mg tablets on Days 1 to 14 of each 21-day treatment cycle until disease progression (DP), development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
Overall Number of Participants Analyzed 79
Mean (Standard Deviation)
Unit of Measure: mg/ week
716.66  (220.945)
9.Secondary Outcome
Title Dose Intensity Per Week of Durvalumab
Hide Description Dose intensity was the cumulative dose divided by the dosing period in weeks).
Time Frame Up to 30 Aug 2017 for nab-paclitaxel and CC-486 + nab-paclitaxel and 23 Dec 2017 for Durva + nab-paclitaxel; maximum treatment duration = 82.1 weeks, 52.6 weeks and 66.1 weeks for nab-paclitaxel, CC-486 + nab-paclitaxel and Durva + nab-paclitaxel
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Hide Analysis Population Description
The treated population consisted of all participants who randomized or assigned and received at least 1 dose of investigational Product.
Arm/Group Title Nab-Paclitaxel + Durvalumab Combination Arm
Hide Arm/Group Description:
Participants received nab-paclitaxel 100 mg/m^2 by IV infusion over 30 minutes on Days 1and 8 and durvalumab (durva) 1125 mg/m^2 by IV infusion over 1 hour on Day 15 of each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
Overall Number of Participants Analyzed 77
Mean (Standard Deviation)
Unit of Measure: mg/week
279.96  (97.304)
10.Secondary Outcome
Title Percentage of Participants With Study Drug Dose Reductions
Hide Description A dose reduction occurred when the dose assigned at a visit was lower than the dose assigned at the previous visit. Dose reductions were typically caused by clinically significant laboratory abnormalities and/or TEAEs or toxicities.
Time Frame Up to 16 Jan 2017 for CC-486 + nab-paclitaxel and up to 23 Dec 2017 for nab-paclitaxel and Durva + nab-paclitaxel; maximum treatment duration = 82.1 weeks, 52.6 weeks and 66.1 weeks for nab-paclitaxel, CC-486 + nab-paclitaxel and Durva + nab-paclitaxel
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Hide Analysis Population Description
The treated population consisted of all participants who were randomized or assigned and received at least 1 dose of investigational product.
Arm/Group Title Nab-Paclitaxel + CC-486 Combination Arm Nab-Paclitaxel + Durvalumab Combination Arm Nab-Paclitaxel Alone
Hide Arm/Group Description:
Participants received nab-paclitaxel 100 mg/m^2 by intravenous (IV) infusion over 30 minutes on Days 8 and 15 and CC-486 200 mg tablets on Days 1 to 14 of each 21-day treatment cycle until disease progression (DP), development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
Participants received nab-paclitaxel 100 mg/m^2 by IV infusion over 30 minutes on Days 1and 8 and durvalumab (durva) 1125 mg/m^2 by IV infusion over 1 hour on Day 15 of each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
Participants received nab-paclitaxel 100 mg/m^2 by intravenous infusion over 30 minutes on Days 1 and 8 each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
Overall Number of Participants Analyzed 79 78 79
Measure Type: Number
Unit of Measure: Percentage of Participants
Nab-Paclitaxel Number Analyzed 79 participants 78 participants 79 participants
10.1 14.1 10.1
CC-486 Number Analyzed 79 participants 0 participants 0 participants
20.3
Durvalumab (Reductions Not Allowed per Protocol) Number Analyzed 0 participants 78 participants 0 participants
0.0
Time Frame TEAEs were collected up to 4 weeks after receiving last dose of IP for nab-paclitaxel and CC-486 + nab-paclitaxel, and up to 90 days after the last IP dose for Durva + nab-paclitaxel; TEAEs were collected up to 86.1 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Nab-Paclitaxel + CC-486 Combination Arm Nab-Paclitaxel + Durvalumab Combination Arm Nab-Paclitaxel Monotherapy Arm
Hide Arm/Group Description Participants received nab-paclitaxel 100 mg/m^2 by intravenous (IV) infusion over 30 minutes on Days 8 and 15 and CC-486 200 mg tablets on Days 1 to 14 of each 21-day treatment cycle until disease progression (DP), development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care. Participants received nab-paclitaxel 100 mg/m^2 by IV infusion over 30 minutes on Days 1and 8 and durvalumab (durva) 1125 mg/m^2 by IV infusion over 1 hour on Day 15 of each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care. Participants received nab-paclitaxel 100 mg/m^2 by intravenous infusion over 30 minutes on Days 1 and 8 each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
All-Cause Mortality
Nab-Paclitaxel + CC-486 Combination Arm Nab-Paclitaxel + Durvalumab Combination Arm Nab-Paclitaxel Monotherapy Arm
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   53/81 (65.43%)   44/79 (55.70%)   37/80 (46.25%) 
Hide Serious Adverse Events
Nab-Paclitaxel + CC-486 Combination Arm Nab-Paclitaxel + Durvalumab Combination Arm Nab-Paclitaxel Monotherapy Arm
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   30/79 (37.97%)   37/78 (47.44%)   29/79 (36.71%) 
Blood and lymphatic system disorders       
Anaemia † 1  0/79 (0.00%)  1/78 (1.28%)  0/79 (0.00%) 
Febrile neutropenia † 1  1/79 (1.27%)  0/78 (0.00%)  0/79 (0.00%) 
Cardiac disorders       
Atrial fibrillation † 1  0/79 (0.00%)  1/78 (1.28%)  0/79 (0.00%) 
Cardiac failure † 1  0/79 (0.00%)  0/78 (0.00%)  1/79 (1.27%) 
Endocrine disorders       
Adrenal insufficiency † 1  0/79 (0.00%)  3/78 (3.85%)  0/79 (0.00%) 
Gastrointestinal disorders       
Abdominal pain † 1  2/79 (2.53%)  0/78 (0.00%)  0/79 (0.00%) 
Diarrhoea † 1  1/79 (1.27%)  1/78 (1.28%)  0/79 (0.00%) 
Duodenal obstruction † 1  0/79 (0.00%)  0/78 (0.00%)  1/79 (1.27%) 
Flatulence † 1  1/79 (1.27%)  0/78 (0.00%)  0/79 (0.00%) 
Intestinal obstruction † 1  1/79 (1.27%)  0/78 (0.00%)  0/79 (0.00%) 
Nausea † 1  1/79 (1.27%)  1/78 (1.28%)  1/79 (1.27%) 
Vomiting † 1  2/79 (2.53%)  1/78 (1.28%)  1/79 (1.27%) 
General disorders       
Death † 1  0/79 (0.00%)  1/78 (1.28%)  0/79 (0.00%) 
General physical health deterioration † 1  2/79 (2.53%)  2/78 (2.56%)  1/79 (1.27%) 
Performance status decreased † 1  2/79 (2.53%)  1/78 (1.28%)  0/79 (0.00%) 
Pyrexia † 1  3/79 (3.80%)  2/78 (2.56%)  1/79 (1.27%) 
Sudden death † 1  1/79 (1.27%)  0/78 (0.00%)  0/79 (0.00%) 
Infections and infestations       
Abdominal wall abscess † 1  1/79 (1.27%)  0/78 (0.00%)  0/79 (0.00%) 
Bronchitis † 1  1/79 (1.27%)  0/78 (0.00%)  0/79 (0.00%) 
Cellulitis † 1  0/79 (0.00%)  1/78 (1.28%)  0/79 (0.00%) 
Infection † 1  0/79 (0.00%)  0/78 (0.00%)  1/79 (1.27%) 
Influenza † 1  1/79 (1.27%)  0/78 (0.00%)  0/79 (0.00%) 
Lower respiratory tract infection † 1  1/79 (1.27%)  2/78 (2.56%)  1/79 (1.27%) 
Lung infection † 1  0/79 (0.00%)  1/78 (1.28%)  0/79 (0.00%) 
Pneumocystis jirovecii pneumonia † 1  0/79 (0.00%)  1/78 (1.28%)  0/79 (0.00%) 
Pneumonia † 1  5/79 (6.33%)  8/78 (10.26%)  3/79 (3.80%) 
Pneumonia pneumococcal † 1  1/79 (1.27%)  0/78 (0.00%)  0/79 (0.00%) 
Postoperative wound infection † 1  0/79 (0.00%)  0/78 (0.00%)  1/79 (1.27%) 
Respiratory tract infection † 1  2/79 (2.53%)  0/78 (0.00%)  1/79 (1.27%) 
Sepsis † 1  0/79 (0.00%)  0/78 (0.00%)  1/79 (1.27%) 
Septic shock † 1  0/79 (0.00%)  1/78 (1.28%)  1/79 (1.27%) 
Upper respiratory tract infection † 1  0/79 (0.00%)  2/78 (2.56%)  0/79 (0.00%) 
Urinary tract infection † 1  1/79 (1.27%)  0/78 (0.00%)  0/79 (0.00%) 
Injury, poisoning and procedural complications       
Femur fracture † 1  0/79 (0.00%)  1/78 (1.28%)  0/79 (0.00%) 
Postoperative fever † 1  0/79 (0.00%)  1/78 (1.28%)  0/79 (0.00%) 
Procedural pneumothorax † 1  0/79 (0.00%)  1/78 (1.28%)  0/79 (0.00%) 
Investigations       
Blood glucose increased † 1  1/79 (1.27%)  0/78 (0.00%)  0/79 (0.00%) 
Blood sodium decreased † 1  0/79 (0.00%)  1/78 (1.28%)  0/79 (0.00%) 
Liver function test abnormal † 1  0/79 (0.00%)  1/78 (1.28%)  0/79 (0.00%) 
White blood cell count increased † 1  0/79 (0.00%)  1/78 (1.28%)  0/79 (0.00%) 
Metabolism and nutrition disorders       
Decreased appetite † 1  1/79 (1.27%)  0/78 (0.00%)  0/79 (0.00%) 
Hyponatraemia † 1  0/79 (0.00%)  1/78 (1.28%)  0/79 (0.00%) 
Metabolic alkalosis † 1  0/79 (0.00%)  0/78 (0.00%)  1/79 (1.27%) 
Musculoskeletal and connective tissue disorders       
Arthralgia † 1  0/79 (0.00%)  0/78 (0.00%)  1/79 (1.27%) 
Back pain † 1  2/79 (2.53%)  0/78 (0.00%)  1/79 (1.27%) 
Muscular weakness † 1  0/79 (0.00%)  1/78 (1.28%)  0/79 (0.00%) 
Pain in extremity † 1  0/79 (0.00%)  1/78 (1.28%)  0/79 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Cancer pain † 1  1/79 (1.27%)  0/78 (0.00%)  0/79 (0.00%) 
Metastases to meninges † 1  1/79 (1.27%)  0/78 (0.00%)  0/79 (0.00%) 
Nervous system disorders       
Aphasia † 1  0/79 (0.00%)  1/78 (1.28%)  0/79 (0.00%) 
Balance disorder † 1  0/79 (0.00%)  1/78 (1.28%)  0/79 (0.00%) 
Cerebrovascular accident † 1  0/79 (0.00%)  1/78 (1.28%)  0/79 (0.00%) 
Epilepsy † 1  0/79 (0.00%)  0/78 (0.00%)  2/79 (2.53%) 
Generalised tonic-clonic seizure † 1  1/79 (1.27%)  0/78 (0.00%)  0/79 (0.00%) 
Headache † 1  1/79 (1.27%)  1/78 (1.28%)  0/79 (0.00%) 
Hemiparesis † 1  1/79 (1.27%)  0/78 (0.00%)  0/79 (0.00%) 
Paraparesis † 1  1/79 (1.27%)  0/78 (0.00%)  0/79 (0.00%) 
Seizure † 1  0/79 (0.00%)  1/78 (1.28%)  0/79 (0.00%) 
Spinal cord compression † 1  0/79 (0.00%)  0/78 (0.00%)  1/79 (1.27%) 
Psychiatric disorders       
Confusional state † 1  1/79 (1.27%)  1/78 (1.28%)  0/79 (0.00%) 
Renal and urinary disorders       
Acute kidney injury † 1  1/79 (1.27%)  0/78 (0.00%)  1/79 (1.27%) 
Dysuria † 1  0/79 (0.00%)  0/78 (0.00%)  1/79 (1.27%) 
Haematuria † 1  1/79 (1.27%)  0/78 (0.00%)  0/79 (0.00%) 
Urinary tract obstruction † 1  1/79 (1.27%)  0/78 (0.00%)  0/79 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Acute respiratory distress syndrome † 1  1/79 (1.27%)  0/78 (0.00%)  0/79 (0.00%) 
Chronic obstructive pulmonary disease † 1  0/79 (0.00%)  1/78 (1.28%)  0/79 (0.00%) 
Dyspnoea † 1  4/79 (5.06%)  1/78 (1.28%)  4/79 (5.06%) 
Hypoxia † 1  0/79 (0.00%)  1/78 (1.28%)  0/79 (0.00%) 
Interstitial lung disease † 1  1/79 (1.27%)  0/78 (0.00%)  0/79 (0.00%) 
Pleural effusion † 1  2/79 (2.53%)  0/78 (0.00%)  4/79 (5.06%) 
Pneumonitis † 1  0/79 (0.00%)  2/78 (2.56%)  1/79 (1.27%) 
Pneumothorax spontaneous † 1  0/79 (0.00%)  0/78 (0.00%)  1/79 (1.27%) 
Pulmonary embolism † 1  3/79 (3.80%)  3/78 (3.85%)  1/79 (1.27%) 
Pulmonary haemorrhage † 1  0/79 (0.00%)  2/78 (2.56%)  0/79 (0.00%) 
Respiratory distress † 1  1/79 (1.27%)  0/78 (0.00%)  0/79 (0.00%) 
Respiratory failure † 1  0/79 (0.00%)  3/78 (3.85%)  0/79 (0.00%) 
Vascular disorders       
Circulatory collapse † 1  1/79 (1.27%)  0/78 (0.00%)  0/79 (0.00%) 
Deep vein thrombosis † 1  0/79 (0.00%)  1/78 (1.28%)  0/79 (0.00%) 
Orthostatic hypotension † 1  0/79 (0.00%)  1/78 (1.28%)  0/79 (0.00%) 
1
Term from vocabulary, MedDRA 19.0
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Nab-Paclitaxel + CC-486 Combination Arm Nab-Paclitaxel + Durvalumab Combination Arm Nab-Paclitaxel Monotherapy Arm
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   78/79 (98.73%)   76/78 (97.44%)   78/79 (98.73%) 
Blood and lymphatic system disorders       
Anaemia † 1  12/79 (15.19%)  23/78 (29.49%)  24/79 (30.38%) 
Leukopenia † 1  5/79 (6.33%)  1/78 (1.28%)  3/79 (3.80%) 
Neutropenia † 1  15/79 (18.99%)  14/78 (17.95%)  10/79 (12.66%) 
Ear and labyrinth disorders       
Vertigo † 1  4/79 (5.06%)  2/78 (2.56%)  3/79 (3.80%) 
Endocrine disorders       
Hypothyroidism † 1  0/79 (0.00%)  5/78 (6.41%)  0/79 (0.00%) 
Eye disorders       
Vision blurred † 1  4/79 (5.06%)  1/78 (1.28%)  0/79 (0.00%) 
Gastrointestinal disorders       
Abdominal pain † 1  7/79 (8.86%)  3/78 (3.85%)  8/79 (10.13%) 
Abdominal pain upper † 1  3/79 (3.80%)  4/78 (5.13%)  2/79 (2.53%) 
Constipation † 1  32/79 (40.51%)  20/78 (25.64%)  26/79 (32.91%) 
Diarrhoea † 1  33/79 (41.77%)  27/78 (34.62%)  19/79 (24.05%) 
Dyspepsia † 1  5/79 (6.33%)  4/78 (5.13%)  6/79 (7.59%) 
Haemorrhoids † 1  4/79 (5.06%)  1/78 (1.28%)  0/79 (0.00%) 
Nausea † 1  45/79 (56.96%)  18/78 (23.08%)  20/79 (25.32%) 
Stomatitis † 1  8/79 (10.13%)  6/78 (7.69%)  8/79 (10.13%) 
Vomiting † 1  42/79 (53.16%)  10/78 (12.82%)  17/79 (21.52%) 
General disorders       
Asthenia † 1  26/79 (32.91%)  36/78 (46.15%)  25/79 (31.65%) 
Chills † 1  0/79 (0.00%)  2/78 (2.56%)  4/79 (5.06%) 
Fatigue † 1  24/79 (30.38%)  22/78 (28.21%)  23/79 (29.11%) 
General physical health deterioration † 1  4/79 (5.06%)  4/78 (5.13%)  1/79 (1.27%) 
Non-cardiac chest pain † 1  3/79 (3.80%)  5/78 (6.41%)  5/79 (6.33%) 
Oedema peripheral † 1  12/79 (15.19%)  11/78 (14.10%)  15/79 (18.99%) 
Pyrexia † 1  10/79 (12.66%)  13/78 (16.67%)  7/79 (8.86%) 
Infections and infestations       
Bronchitis † 1  2/79 (2.53%)  1/78 (1.28%)  4/79 (5.06%) 
Lower respiratory tract infection † 1  1/79 (1.27%)  11/78 (14.10%)  3/79 (3.80%) 
Nasopharyngitis † 1  5/79 (6.33%)  4/78 (5.13%)  5/79 (6.33%) 
Oral candidiasis † 1  5/79 (6.33%)  3/78 (3.85%)  4/79 (5.06%) 
Respiratory tract infection † 1  2/79 (2.53%)  9/78 (11.54%)  4/79 (5.06%) 
Upper respiratory tract infection † 1  3/79 (3.80%)  20/78 (25.64%)  8/79 (10.13%) 
Urinary tract infection † 1  2/79 (2.53%)  10/78 (12.82%)  4/79 (5.06%) 
Investigations       
Alanine aminotransferase increased † 1  2/79 (2.53%)  4/78 (5.13%)  0/79 (0.00%) 
Blood creatinine increased † 1  0/79 (0.00%)  4/78 (5.13%)  1/79 (1.27%) 
Neutrophil count decreased † 1  5/79 (6.33%)  0/78 (0.00%)  4/79 (5.06%) 
Weight decreased † 1  9/79 (11.39%)  2/78 (2.56%)  5/79 (6.33%) 
Metabolism and nutrition disorders       
Decreased appetite † 1  27/79 (34.18%)  26/78 (33.33%)  24/79 (30.38%) 
Hypomagnesaemia † 1  2/79 (2.53%)  5/78 (6.41%)  6/79 (7.59%) 
Hyponatraemia † 1  1/79 (1.27%)  4/78 (5.13%)  2/79 (2.53%) 
Hypophosphataemia † 1  3/79 (3.80%)  2/78 (2.56%)  4/79 (5.06%) 
Musculoskeletal and connective tissue disorders       
Arthralgia † 1  11/79 (13.92%)  9/78 (11.54%)  14/79 (17.72%) 
Back pain † 1  4/79 (5.06%)  9/78 (11.54%)  7/79 (8.86%) 
Muscle spasms † 1  5/79 (6.33%)  1/78 (1.28%)  3/79 (3.80%) 
Muscular weakness † 1  4/79 (5.06%)  1/78 (1.28%)  1/79 (1.27%) 
Musculoskeletal chest pain † 1  3/79 (3.80%)  4/78 (5.13%)  1/79 (1.27%) 
Musculoskeletal pain † 1  7/79 (8.86%)  6/78 (7.69%)  5/79 (6.33%) 
Myalgia † 1  9/79 (11.39%)  4/78 (5.13%)  7/79 (8.86%) 
Neck pain † 1  0/79 (0.00%)  4/78 (5.13%)  7/79 (8.86%) 
Pain in extremity † 1  6/79 (7.59%)  4/78 (5.13%)  7/79 (8.86%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Cancer pain † 1  2/79 (2.53%)  9/78 (11.54%)  4/79 (5.06%) 
Nervous system disorders       
Dizziness † 1  8/79 (10.13%)  3/78 (3.85%)  9/79 (11.39%) 
Headache † 1  9/79 (11.39%)  8/78 (10.26%)  10/79 (12.66%) 
Paraesthesia † 1  10/79 (12.66%)  1/78 (1.28%)  3/79 (3.80%) 
Peripheral motor neuropathy † 1  0/79 (0.00%)  3/78 (3.85%)  5/79 (6.33%) 
Peripheral sensory neuropathy † 1  19/79 (24.05%)  23/78 (29.49%)  22/79 (27.85%) 
Psychiatric disorders       
Anxiety † 1  5/79 (6.33%)  2/78 (2.56%)  4/79 (5.06%) 
Depressed mood † 1  0/79 (0.00%)  4/78 (5.13%)  1/79 (1.27%) 
Insomnia † 1  9/79 (11.39%)  6/78 (7.69%)  8/79 (10.13%) 
Respiratory, thoracic and mediastinal disorders       
Cough † 1  16/79 (20.25%)  19/78 (24.36%)  21/79 (26.58%) 
Dyspnoea † 1  16/79 (20.25%)  19/78 (24.36%)  22/79 (27.85%) 
Epistaxis † 1  3/79 (3.80%)  5/78 (6.41%)  7/79 (8.86%) 
Haemoptysis † 1  4/79 (5.06%)  6/78 (7.69%)  6/79 (7.59%) 
Pleural effusion † 1  6/79 (7.59%)  1/78 (1.28%)  1/79 (1.27%) 
Productive cough † 1  3/79 (3.80%)  10/78 (12.82%)  5/79 (6.33%) 
Pulmonary embolism † 1  7/79 (8.86%)  2/78 (2.56%)  2/79 (2.53%) 
Rhinorrhoea † 1  2/79 (2.53%)  4/78 (5.13%)  3/79 (3.80%) 
Skin and subcutaneous tissue disorders       
Alopecia † 1  25/79 (31.65%)  25/78 (32.05%)  21/79 (26.58%) 
Dry skin † 1  6/79 (7.59%)  3/78 (3.85%)  3/79 (3.80%) 
Rash erythematous † 1  0/79 (0.00%)  4/78 (5.13%)  0/79 (0.00%) 
Vascular disorders       
Flushing † 1  1/79 (1.27%)  0/78 (0.00%)  4/79 (5.06%) 
Hypotension † 1  2/79 (2.53%)  3/78 (3.85%)  4/79 (5.06%) 
1
Term from vocabulary, MedDRA 19.0
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results from a center cannot be submitted for publication before results of multicenter study are published unless it is more than one year since study completion.Then, Investigator can publish if manuscript is submitted to Celgene 60 days prior to submission. If Celgene decides publication would hinder drug development, Investigator must delay submission for up to ninety days. Investigator must delete confidential information before submission or defer publication to permit patent applications.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Anne McClain, Senior Manager, Clinical Trial Disclosure
Organization: Celgene Corporation
Phone: 1-888-260-1599
EMail: ClinicalTrialDisclosure@Celgene.com
Publications:
Layout table for additonal information
Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT02250326    
Other Study ID Numbers: ABI-007-NSCL-006
2014-001105-41 ( EudraCT Number )
First Submitted: September 24, 2014
First Posted: September 26, 2014
Results First Submitted: July 13, 2018
Results First Posted: August 10, 2018
Last Update Posted: December 30, 2019